Press Release

LEO Pharma Reinforces Leadership in Medical Dermatology with New Data from Across Its Portfolio at 2025 Fall Clinical Dermatology Conference

MADISON, N.J.–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, is advancing the understanding of skin disease and its impact on patients’ lives with the presentation of 46 abstracts at the upcoming 2025 Fall Clinical Dermatology Conference taking place from Oct 23 – 26 in Las Vegas, Nevada. The data span multiple forms of skin disease, including chronic hand eczema (CHE), atopic dermatitis (AD), generalized pustular psoriasis (GPP) and pyoderma gangrenosum (PG).


“Fall Clinical Dermatology Conference is an important conference for researchers and clinicians specializing in dermatology, and we’re excited about the wealth of new data we will share at this meeting that can help advance dermatological care for those living with debilitating skin diseases,” said Shannon Schneider, Vice President of North America Medical Affairs for LEO Pharma. “Our deep commitment to advancing science and medicine is reflected in the large volume of new data, which spans a spectrum of dermatologic conditions and offers a more holistic perspective on the patient experience, real-world safety, efficacy, and the health economic impact of our treatments.”

Key data to be presented at the 2025 Fall Clinical Dermatology Conference by LEO Pharma include:

  • The first U.S. prevalence data on CHE, based on a survey of more than 10,000 people. The CHECK study includes findings on demographics, disease severity, healthcare resource utilization, and ability to work among CHE patients.1-5
  • New health economics and outcomes data that explores the burden of CHE in the U.S. and analyzes the potential financial impact of ANZUPGO® (delgocitinib) cream on a U.S. Commercial Health plan.7-10
  • Real-world ADBRY® (tralokinumab-ldrm) data, evaluating the safety and effectiveness of up to 12 months of treatment for patients with moderate to severe AD.21-27
  • New findings examining the burden of GPP in the U.S., as well as the effect of treatments such as SPEVIGO® (spesolimab).35-37

At the 2025 Fall Clinical Dermatology Conference, LEO Pharma will unveil its first data presentations on GPP and SPEVIGO since acquiring the product from Boehringer Ingelheim. SPEVIGO is now the third asset in LEO Pharma’s global portfolio.

The company’s full roster of presentations at the 2025 Fall Clinical Dermatology Conference can be found in the table below.1-46

Title

Author

Presentation details

Delgocitinib and Chronic Hand Eczema (CHE)

CHE treatment burden: Results from a survey of dermatology healthcare professionals

Raj Chovatiya

Poster presentation

Demographics, clinical, and treatment characteristics of patients with moderate-to-severe CHE in the United States – a retrospective claims analysis

April Armstrong

Poster presentation

Demographics and clinical characteristics of CHE patients – results from the CHECK study in the United States

Eric Simpson

Poster presentation

Prevalence of self-reported physician diagnosis of CHE in adults: A cross-sectional study of more than 10,000 participants in the general population – Results from the CHECK study in the United States

Raj Chovatiya

Poster presentation

Self-reported disease severity, symptoms, and treatment of CHE – results from the CHECK study in the United States

Raj Chovatiya

Poster presentation

Healthcare resource utilization and financial burden among patients with CHE – results from the CHECK study in the United States

Raj Chovatiya

Poster presentation

The impact of CHE on occupation, work productivity, and activity impairment – results from the CHECK study in the United States

Eric Simpson

Poster presentation

Hand eczema workers’ compensation claims: Real-World Data Analysis in the United States

Richard Brook

Poster presentation

Cost-per-responder analysis of delgocitinib topical cream versus dupilumab subcutaneous injection for moderate to severe atopic hand eczema in the United States

Sanjeev Balu

Poster presentation

Budget impact analysis of delgocitinib for moderate-to-severe chronic hand eczema in the United States

Jianni Singh-Landa

Poster presentation

Delgocitinib cream has negligible systemic exposure in patients with maximal use of delgocitinib cream for the treatment of CHE

Melinda Gooderham

Poster presentation

“Super-response” following treatment with delgocitinib cream 20 mg/g in a subgroup of patients with moderate to severe CHE

April Armstrong

Poster presentation

Patient reported outcomes and symptom improvements across subtypes of Chronic Hand Eczema: outcomes from the Phase 3 DELTA-1 and DELTA-2 trials

Robert Bissonnette

Poster presentation

Delgocitinib cream improves pain and health-related quality of life in patients with CHE with severe pain

Robert Bissonnette

Poster presentation

Matching-adjusted indirect comparison of the efficacy at week 12 of Delgocitinib and topical PUVA in the treatment of severe CHE

April Armstrong

Poster presentation

Treatment with delgocitinib cream is associated with a reduction of Staphylococcus aureus density and pain in patients with mild to severe CHE

Tove Agner

Poster presentation

Aetiological subtypes of moderate to severe CHE: Signs, symptoms and localisations – results from the RWEAL study

Maria Concetta Fargnoli

Poster presentation

Patient perspectives in moderate-to-severe chronic hand eczema: Understanding patient experience and factors influencing treatment preference through in-depth qualitative patient interviews in the US

April Armstrong

Poster presentation

DELTA TEEN Phase 3 trial: Efficacy and safety of Delgocitinib cream in adolescents with moderate to severe CHE

Sonja Molin

Poster presentation

Safety of delgocitinib cream in adult patients with mild to severe CHE: pooled analysis of five phase 2b and phase 3 trials

Robert Bissonnette

Poster presentation

Tralokinumab

Reduced dosing frequency with tralokinumab provides sustained improvements in symptoms and quality of life up to 1 year in adults with moderate-to-severe AD

April Armstrong

Poster presentation

Real-world effectiveness of up to 12-months tralokinumab treatment in adults with AD who previously failed dupilumab or Janus kinase inhibitors

April Armstrong

Poster presentation

Safety and adverse events of special interest in 825 adults with atopic dermatitis receiving up to 12 months of tralokinumab treatment in a real-world setting

Cory Rubin

Poster presentation

Real-world safety and effectiveness of up to 12-months tralokinumab treatment in adults with AD who discontinued dupilumab due to conjunctivitis

April Armstrong

Poster presentation

Tralokinumab improves patient-reported outcomes in adults with moderate-to-severe AD in the United States: real-world data from a 52-week assessment

Peter Lio

Poster presentation

Estimated conjunctivitis-related healthcare cost savings with increased tralokinumab use versus other biologics among patients with moderate-severe AD in the United States

Sanjeev Balu

Poster presentation

Treatment-free disease control after tralokinumab in patients with moderate-to-severe AD

Andrew Blauvelt

Poster presentation

Pharmacokinetics (PK) and safety of tralokinumab in children (aged 6 to <12 years) with moderate-to-severe AD: an interim analysis of the TRAPEDS 1 phase 2 trial

Michael Cork

Poster presentation

Long-term efficacy with tralokinumab in patients with moderate-to-severe AD: final results from the 5-year ECZTEND study

Andrew Blauvelt

Poster presentation

Effectiveness and safety of 12-months tralokinumab treatment in 824 adults with AD: Final real-world data from the prospective, non-interventional, international, single-cohort TRACE study

April Armstrong

Poster presentation

Patient-reported outcomes evaluations of 12-months tralokinumab treatment in 824 adults with AD: Real-world data from the prospective, non-interventional, international, single-cohort TRACE study

Ahmed Ameen

Poster presentation

Effectiveness of 12-months tralokinumab treatment in 654 adults with AD with head & neck area involvement: Final real-world data from the prospective, non-interventional, international, single-cohort TRACE study

Marni Wiseman

Poster presentation

Initial “Super Response” to Tralokinumab Leads to stable long-term response in patients with moderate-to-severe AD: Responder and predictor analysis from the ECZTRA 3 & ECZTEND Trials

Andrew Blauvelt

Poster presentation

Spesolimab and Generalized Pustular Psoriasis (GPP)

EFFISAYIL OBSERVE: A real-world descriptive study of patients with GPP in the USA

Mark Lebwohl

Poster presentation

Understanding the chronicity of GPP and the effect of treatment: a structured review

Joseph Merola

Poster presentation

Spesolimab improves quality of life in GPP as measured by proportion of patients with Dermatology Life Quality Index (DLQI) scores of 0 or 1 and reduction in pain severity over time: Results from the EFFISAYIL® 2 trial

Tina Bhutani

Poster presentation

Spesolimab for the treatment of generalized pustular psoriasis flares: Preliminary analysis of the EFFISAYIL REP study

Siew Eng Choon

Poster presentation

GPP: A systematic literature review of mortality and comorbidity data

Mark Lebwohl

Poster presentation

GPP control is limited on traditional small-molecule therapy as measured by the GPP Physician Global Assessment (GPPGA) and Dermatology Life Quality Index (DLQI): Baseline data from the Effisayil® 2 trial

Arash Mostaghimi

Poster presentation

Spesolimab improves Generalized Pustular Psoriasis Physicians Global Assessment (GPPGA), affected body surface area (BSA), and quality of life (QoL) in GPP: EFFISAYIL® 2 trial analyses

Bruce Strober

Poster presentation

Flare burden in GPP: analysis of pre-trial historical experience of patients enrolled in EFFISAYIL® 2

Milan Anadkat

Poster presentation

Long-term management of chronic GPP with subcutaneous spesolimab: A case report

Angad Chadha

Poster presentation

Spesolimab impact on health status among patients with GPP measured by EQ-5D-5L: Results from the EFFISAYIL® 2 trial

Matthias Augustin

Poster presentation

The impact of spesolimab on health-related quality of life (HRQoL) measured by the short form-36 (SF-36) among patients with GPP: Results from the EFFISAYIL® 2 trial

Alice Gottlieb

Poster presentation

Pyoderma Gangrenosum (PG)

 

 

The emotional impact of PG: Real-world experience of the PG patient journey

Afsaneh Alavi

Poster presentation

Randomized Phase 3 trial of spesolimab in patients with ulcerative pyoderma gangrenosum: A study protocol

Mark Lebwohl

Poster presentation

About Chronic Hand Eczema

Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.47 HE is one of the most common skin disorders of the hands and in a substantial number of patients, it can develop into a chronic condition.48 CHE affects approximately one in ten adults worldwide.49,50 It is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.47 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.49

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,51,52 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities.53 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.54

About Atopic Dermatitis

Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.55 AD is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.56 Type 2 cytokines, including IL-13, play an important role in the key aspects of AD pathophysiology.55,56 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.57

About Generalized Pustular Psoriasis

Generalized pustular psoriasis (GPP) is a chronic, heterogeneous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment.58,59 GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems.60,61 GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances.61,62

About ANZUPGO® (delgocitinib) Cream

ANZUPGO® (delgocitinib) cream is currently FDA-approved in the U.S. as the first and only topical pan-JAK treatment for chronic hand eczema (CHE). Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.63 ANZUPGO cream is also approved in the European Union, United Kingdom, Switzerland, United Arab Emirates and Canada under the brand name ANZUPGO for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or not advisable. ANZUPGO cream is also under investigation in other markets.

ANZUPGO cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.64

In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ANZUPGO® (DELGOCITINIB) CREAM

What is ANZUPGO?

ANZUPGO is a prescription medicine used on the skin (topical) to treat moderate to severe chronic hand eczema (CHE) in adults who are not well-controlled with or cannot use topical corticosteroids.

The use of ANZUPGO along with other JAK inhibitors or strong immunosuppressants is not recommended.

IMPORTANT SAFETY INFORMATION

ANZUPGO is for use on the skin (topical use) only. Do not use ANZUPGO in or on your eyes, mouth, or vagina.

What is the most important information I should know about ANZUPGO?

ANZUPGO may cause serious side effects, including:

Serious Infections: ANZUPGO may increase your risk of infections. ANZUPGO contains delgocitinib. Delgocitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth or applying on the skin, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections.

  • ANZUPGO should not be used in people with an active, serious infection. You should not start using ANZUPGO if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) or eczema herpeticum (a blistery, painful skin rash) during treatment with ANZUPGO.

Before starting ANZUPGO, tell your healthcare provider if you:

  • are being treated for an infection or have an infection that does not go away or that keeps coming back
  • have TB or have been in close contact with someone with TB
  • have had shingles (herpes zoster)
  • have had hepatitis B or C
  • think you have an infection or have symptoms of an infection such as fever, sweating, or chills; muscle aches; cough or shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinating more often than usual; and/or feeling very tired

After starting ANZUPGO, call your healthcare provider right away if you have any symptoms of an infection. ANZUPGO can make you more likely to get infections or make worse any infections that you have. If you get a serious infection, your healthcare provider may stop your treatment with ANZUPGO until your infection is controlled.

Non-melanoma skin cancer. ANZUPGO may increase your risk of certain non-melanoma skin cancers. Your healthcare provider will regularly check your skin during your treatment with ANZUPGO.

  • Avoid sunlamps and limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun, and use a broad-spectrum sunscreen
  • Tell your healthcare provider if you have ever had any type of cancer

Potential risks from Janus kinase (JAK) inhibition. It is not known whether using ANZUPGO has the same risks as taking oral or other topical JAK inhibitors. Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least one heart disease (cardiovascular) risk factor who were taking a JAK inhibitor used to treat rheumatoid arthritis (RA) compared to people taking another medicine in a class of medicines called TNF blockers. ANZUPGO is not for use in people with RA. Oral or other topical JAK inhibitors have also caused increased cholesterol.

Before using ANZUPGO, tell your healthcare provider about all your medical conditions, including if you:

  • have an infection
  • have recently received or are scheduled to receive a vaccine. People who use ANZUPGO should not receive live vaccines right before starting, during treatment, or right after treatment with ANZUPGO
  • are pregnant or plan to become pregnant. It is not known if ANZUPGO will harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if ANZUPGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ANZUPGO. If you use ANZUPGO while breastfeeding, avoid touching the nipple and surrounding area right away after applying ANZUPGO to your hands and wrists

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of ANZUPGO?

  • application site reactions, including pain, tingling, itching, and redness; bacterial skin infections, including finger cellulitis and nail infections; and low white blood cells

These are not all of the possible side effects of ANZUPGO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide.

About ADBRY® (tralokinumab-ldrm) / ADTRALZA® (tralokinumab)

ADBRY® (tralokinumab-ldrm), which is marketed outside of the U.S. under the tradename ADTRALZA® (tralokinumab), is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.65 Tralokinumab-ldrm specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).66

Tralokinumab-ldrm is approved for the treatment of moderate to severe AD in adult and adolescent patients 12 years and older in the European Union, Canada, Great Britain, the United Arab Emirates, South Korea, the U.S., and Saudi Arabia. Tralokinumab-ldrm is approved for use in adults with moderate to severe AD in Switzerland and Japan.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ADBRY® (TRALOKINUMAB-LDRM)

What is ADBRY?

  • ADBRY® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
  • It is not known if ADBRY is safe and effective in children under 12 years of age.

Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.

What should I discuss with my healthcare provider before starting ADBRY?

Tell your healthcare provider about all your medical conditions, including if you:

  • have eye problems.
  • have a parasitic (helminth) infection.
  • are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.
  • are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.
  • are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ADBRY?

  • See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes and autoinjectors.
  • Use ADBRY exactly as prescribed by your healthcare provider.
  • Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
  • ADBRY comes as a single-dose prefilled syringe with needle guard or as an autoinjector.
  • ADBRY is given as an injection under the skin (subcutaneous injection).
  • If your healthcare provider decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult.
  • If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
  • If you inject too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
  • Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects including:

  • Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

    • breathing problems
    • itching
    • skin rash
    • swelling of the face, mouth, and tongue
    • fainting, dizziness, feeling lightheaded (low blood pressure)
    • hives
  • Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.

Contacts

Elizabeth Gory

LEO Pharma, Interim Head of Communications, U.S.

Email: [email protected]

Jes Broe Frederiksen

LEO Pharma, Senior Manager, Global Product and Data Communications

Email: [email protected]

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